LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM

LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K142160) manufactured by GE Healthcare. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 9, 2014. Regulation: 8.